Psychosocial well-being in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) and their caregivers: A prospective study

Abstract

Abstract Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for many hematologic malignancies. However, both patients and caregivers often experience a significant psychological and emotional burden. This study evaluated distress, quality of life (QoL), and unmet needs in patients undergoing allo-HSCT over 12 months, using a variety of validated psychometric tools. In this single-center, prospective, observational study, between February 2020 and January 2024, 143 patients were screened and 115 were ultimately enrolled after meeting eligibility criteria, including informed consent, language comprehension, and absence of untreated psychiatric diseases. Assessment was conducted at baseline (T0), 6 months (T1), and 12 months after allo-HSCT (T2), with the following tools: Distress Thermometer (DT), Psychological Distress Inventory (PDI), Short Form Health Survey (SF-36), Needs Evaluation Questionnaire (NEQ), and the Family Strain Questionnaire–Short Form (FSQ-SF) for caregivers. Additionally, the Psychosocial Assessment of Candidates for Transplantation (PACT) questionnaire was submitted at T0. Repeated-measures analyses and linear mixed-effects models were used to assess trends and interactions over time. The median age at transplant was 56 years (IQR 48.50 -65.00), with a male-to-female ratio of 69:46 (60% males, 40% females). The most common underlying diagnoses was Acute Myeloid Leukemia (57/115 patients, 50%). This was followed by Myelodysplastic Syndrome (14% of the patients), and Primary or Secondary Myelofibrosis (12% of the patients). Of the 115 enrolled patients', only 80 (70%) performed the PACT questionnaire following the initial psychological assessment. The median value was 38 (IQR 32 – 40). Considering a final score below 29 as the threshold for defining a low PACT score, only 9% of the enrolled patients fell into this category. Among them, 1 patient scored between 0-19, 2 patients between 20-24, and 6 patients between 25-29. At baseline, 67% of patients had clinically significant distress (DT ≥ 4), which slightly increased at T1 (69%) and significantly decreased by T2 (47%; p=0.0012). PDI scores mirrored this trend, peaking at T1 (median: 31.4) and returning near baseline by T2 (median: 28.5). Sex-based analyses showed that females experienced higher PDI scores than males at both T0 (p=0.044) and T1 (p=0.002), with the difference attenuating by T2. Health-related quality of life, assessed via SF-36, showed significant improvements over time in multiple subscales, particularly between 6- and 12-months post-transplant. Notable improvements were observed in physical functioning (T0-T1 p=0.0014; T1-T2 p=0.0019), energy/fatigue (T0-T1 p=0.0007; T1-T2 p=0.0136), emotional well-being (T0-T1 and T1-T2 p=0.0382), social functioning (T1-T2 p=0.00015), pain (T1-T2 p=0.0289), and general health (T0-T1 p=0.011; T1-T2 p=0.0058). NEQ responses revealed that unmet needs, particularly regarding information clarity, future expectations, and communication with medical staff, were higher at T1 and T2, compared to T0. Several items (e.g., need for more honest dialogue with physicians) showed statistically significant improvements across time (adjusted p<0.01). Sex and age modulated these responses; for instance, female patients and younger participants (<48 years) reported greater changes in perceived needs. This study underscores the dynamic nature of psychological distress in allo-HSCT patients, with a peak around 6 months post-transplant and a gradual return to baseline by 12 months. Psychosocial recovery was reflected in improved QoL scores and decreased unmet needs. Distress and perceived needs varied by sex and age, suggesting that personalized, time-sensitive psychological support is essential. Additionally, a structured, longitudinal psychological assessment, embedded within clinical pathways, allows early detection of distress and targeted support, also with the aim to achieve better clinical outcomes. These findings support the integration of psycho-oncology services into HSCT care models and highlight the need to systematically include caregivers in psychosocial evaluations and interventions.